Patricia A. Ganz, MD, discusses the quality of life results from the phase 3 OlympiA trial in BRCA-mutated breast cancer.
Patricia A. Ganz, MD, medical oncologist, director, Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center, lead, Cancer Control and Survivorship, associate director, Population Science Research, University of California, Los Angeles (UCLA) Health, discusses the quality of life (QOL) results from the phase 3 OlympiA trial (NCT02032823) in BRCA-mutated breast cancer.
Findings from the OlympiA trial showed that adjuvant olaparib (Lynparza) was associated with significantly longer invasive disease-free survival (DFS) and distant DFS compared with placebo in patients with high-risk, HER2-negative, early-stage breast cancer who harbored germline BRCA1/BRCA2 pathogenic or likely pathogenic variants after completion of local treatment and neoadjuvant or adjuvant chemotherapy.
During the 2021 San Antonio Breast Cancer Symposium, findings from a QOL analysis of the trial were presented. The results showed that fatigue severity was statistically significantly greater at 6 and 12 months among patients treated with olaparib compared with placebo; however, the difference was not clinically meaningful as it did not meet prespecified criteria. Moreover, no meaningful differences were observed between arms at 18 and 24 months.
A statistically significant difference in nausea/vomiting severity was observed among olaparib-treated vs placebo-treated patients at 6 and 12 months but not at 18 and 24 months. No differences in diarrhea severity were observed.
Moreover, no clinically meaningful differences in global QOL, physical functioning, or mental functioning were observed between olaparib vs placebo, and a gradual improvement of these factors was observed in both arms over the course of 24 months. This was in-line with expectations because patients had received intensive chemotherapy, radiation, and surgery prior to olaparib or placebo, which patients had to recover from. Ultimately, olaparib was not found to significantly contribute to QOL deterioration or changes in recovery, Ganz concludes.